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Идёт набор NCT07666100

Evaluation of Adverse Effects Related to Prescribed Medications in a Periodontology Clinic

— Наблюдательное Having a Periodontal Prescription

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: questionnaire.
Кому может быть актуально
Состояния в реестре: Having a Periodontal Prescription. Базовые параметры: от 16 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Evaluation of Adverse Effects Related to Prescribed Medications in a Periodontology Clinic in Terms of Causality, Severity, and Quality of Life: A Prospective Study

Обзор

Various pharmacological treatment approaches, primarily antibiotics, analgesics, and antiseptic agents, are frequently used in the treatment of periodontal diseases. While these drugs are important for the clinical effectiveness of periodontal treatment, drug-related side effects can negatively impact patient compliance, quality of life, and overall patient safety, and in some cases, may lead to premature termination of treatment. Early identification of drug-related side effects, assessment of causality, and classification of severity form the basis of pharmacovigilance practices. In this context, the Adverse Event Reporting System (FAERS), run by the United States Food and Drug Administration (FDA), is an important data source for detecting drug-related side effects and presenting safety signals. Large databases like FAERS draw attention to potential drug-related side effects and provide valuable information on drug safety. However, this data is largely based on patient/user or physician feedback, and these systems are insufficient to assess the true frequency, clinical severity, and impact on patients' quality of life of side effects. Side effects related to medications prescribed in periodontology clinics are often considered mild or transient, thus limiting systematic feedback based on real-life data. Therefore, systematic and patient-centered clinical studies using standard algorithms and scales based on real-life data are needed. This study aims to determine the frequency of side effects related to medications prescribed in a periodontology clinic over an 18-month period and to evaluate them according to gender and age. As a secondary aim, it aims to evaluate the causal relationship of these side effects with the medications, their clinical severity, and their impact on patients' quality of life related to oral health using a holistic approach. This will ensure that not only the presence of side effects but also clinical and patient-centered outcomes are presented in an objective, standardized, and reproducible manner.

Вмешательства

  • Другое questionnaire
    * It will be classified using the Naranjo algorithm in terms of causality, * It will be evaluated according to the Hartwig-Siegel adverse effect severity scale in terms of severity, * Its impact on quality of life will be measured using a valid and reliable oral health-related quality of life scale (OHIP-14). Sample forms of the Naranjo algorithm, Hartwig-Siegel scale and Quality of Life scale are uploaded as files.

Первичные конечные точки

  • Naranjo algorithm results [Срок оценки: 12 months]
Вторичные конечные точки (2)
  • Hartwig-Siegel Adverse Effect Severity Scale [Срок оценки: 12 months]
  • Oral Health Impact Profile-14 (OHIP-14). [Срок оценки: 12 months]

Критерии участия

Критерии включения

Being 16 years of age or older

  • Receiving treatment at a periodontology clinic • Having been prescribed at least one pharmacological agent
  • Volunteering to participate in the study and providing informed consent

Критерии исключения

  • Having a cognitive problem that would prevent the evaluation of side effects related to drug use
  • Patients who did not come for evaluation during the follow-up period or for whom sufficient follow-up data could not be obtained
  • Patients who provided incomplete, inconsistent or unreliable data regarding side effect evaluation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Sivas Cumhuriyet University — Sivas

Идентификаторы

NCT: NCT07666100 · Ali Kemal YILMAZ

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗